The National Heart, Lung, and Blood Institute (NHLBI) seeks comments on proposed support for research to develop stem cell-derived blood products for transfusion. Responses to this Request for Information (RFI) will assist NHLBI staff in assessing the value of the research areas and provide insight on how the proposed support could be altered to meet the needs of investigators conducting research in the areas related to stem cell-derived blood products.

Background

The NHLBI Workshop on “Stem Cell-derived Blood Products for Transfusion” held September 27, 2013 identified major challenges and unmet needs. Unmet needs include a lack of alternatives to blood products for transfusion provided by voluntary donors. In times of donor shortages and/or national emergencies, a source of blood products for transfusion is a priority. The major challenges to meeting this need include the ability to produce functional and clinically-relevant numbers of stem cell-derived blood products (e.g., red blood cells or platelets) and to do so efficiently and in a cost-effective manner. Many of these challenges require more basic research to advance our knowledge while others require improvement of the cell manufacturing and processing. The cell processing methods require the development of improved techniques and better tools that can help reduce costs while improving yields. The development of those methods and tools is believed to potentially benefit from research by the small business community.

Information Requested

This RFI seeks feedback from the scientific and clinical research communities, the small business community, other interested organizations, and the public on the initiation of the research program to develop stem cell-derived blood products for transfusion. Comments can include but are not limited to the following areas of concern:

1. Benefits to the scientific community from the initiation of a research program related to stem cell-derived blood products for transfusion.

Production of platelets and red blood cells, including differentiation, expansion and storage.

3. Usefulness of these research aspects to the development of stem cell-derived blood products for clinical use. In particular,

Circumstances in which stem cell-derived blood products can be of significant value as a supplement or alternative to blood from donors.

Aspects of research and development for stem cell-derived blood products or other scientific areas that may benefit from this proposed research support.

Readiness of the small business community to translate and commercialize technologies related to stem cell-derived blood products for transfusion.

4. The current state of the science and what additional research topics, if any, are needed for translation and commercialization.

5. Suggestions for additional aspects of research and development that are not listed above but could be helpful for stem cell-derived blood products for transfusion.

Confidentiality

Response to this RFI is voluntary. All interested parties are invited to respond. Any personal identifiers (e.g. names, addresses, E-mail addresses, etc.) will be removed when responses are compiled. Only the de-identified comments will be used. Proprietary, classified, confidential, or sensitive information should not be included in your response. The United States government reserves the right to use any non-proprietary technical information in any resultant funding opportunity announcement(s).

This RFI is for information and planning purposes only and should not be construed as a funding opportunity announcement or as an obligation on the part of the United States government to provide support for any ideas identified in response to it. Please note that the United States government will not pay for the preparation of any information submitted or for its use of that information. Responses will be compiled and shared internally with staff from the NHLBI, and with the National Heart, Lung, and Blood Advisory Council, with one or more subcommittees of the Council, and with scientific working groups convened by the NHLBI, as appropriate. In all cases where responses are shared, the names of the respondents will be withheld.

How to Submit a Response:

Responses to the RFI will be accepted until March 10, 2014. You will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the Unites States government’s use of such information.

All comments must be submitted via email as text or as an attached electronic document. Microsoft Word documents are preferred. Please submit your response to: shimian.zou@nih.gov.